A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight

Phase 1

Active, not recruiting

• Conditions: Obesity; Overweight
• Interventions: Drug: Placebo; Drug: Orforglipron

• Registration Number: NCT06824051
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The main purpose of this study is to see how orforglipron affects the amount of body fat compared with placebo in participants with obesity or overweight. Participation in the study will last approximately 8 months.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-27
• Study First Submitted QC: 2025-02-10
• Study First Posted: 2025-02-13
• Study Start: 2025-02-17
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-22
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Have a Body Mass Index (BMI)

  • ≥30.0 kilograms per square meter (kg/m2), or
  • ≥27.0 kg/m2 with comorbidities

Exclusion Criteria

• Have type 1 diabetes, type 2 diabetes, or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma
• Have an unstable body weight within 90 days prior to screening
• Have acute or chronic hepatitis
• Are taking other medications or alternative remedies to manage weight loss

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will receive placebo orally
Orforglipron	Orforglipron	Participants will receive orforglipron orally

Primary Outcome Measures

Name	Time	Method
Percent Change from Baseline in Visceral Adipose Tissue (VAT)	Baseline, Week 36

Secondary Outcome Measures

Name	Time	Method
Percent Change from Baseline in Energy Intake	Baseline, Week 36
Percent Change from Baseline in Appetite	Baseline, Week 36
Percent Change from Baseline in Fasting Total Cholesterol	Baseline, Week 36
Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hs-CRP)	Baseline, Week 36
Change from Baseline in International Physical Activity Questionnaire-Long Form (IPAQ-L) Scores	Baseline, Week 36
Percent Change from Baseline in Body Weight	Baseline, Week 36

Trial Locations

Locations (4)

Clinical Pharmacology of Miami; 🇺🇸 Miami, Florida, United States

Axis; 🇺🇸 Dilworth, Minnesota, United States

Ohio Clinical Trials; 🇺🇸 Columbus, Ohio, United States

Endeavor Clinical Trials; 🇺🇸 San Antonio, Texas, United States